Senior QA Officer
Role Overview
Our client is seeking a QA Officer to support Good Distribution Practice (GDP) activities, quality management systems, regulatory surveillance and continuous improvement across Irish and global quality operations.
GDP Support
- Support the GDP Responsible Person (RP), including customer oversight meetings, minutes and follow-up actions.
- Prepare and execute shipping risk assessments and shipping verification protocols.
- Record, investigate and close EU, UK and rest-of-world distribution complaints and shipment temperature excursions.
- Act as Deputy Responsible Person for the client’s products.
Quality Metrics & Trending
- Prepare monthly and quarterly Ireland quality metrics, monthly RP oversight reports and local Quality Management Reviews (QMR).
- Identify trends, emerging issues and opportunities for continuous improvement.
- Support the preparation of monthly and quarterly US/global quality metrics and QMR reports.
Regulatory Surveillance & eQMS
- Lead improvements to an electronic regulatory surveillance process aligned with global cGMP requirements, working with the Global Quality Team.
- Conduct quarterly global regulatory surveillance and assess potential impacts on the Quality Management System.
- Develop the binder management process within the Dot Compliance eQMS and carry out routine verification checks.
General Quality Responsibilities
- Progress and approve, as appropriate, deviations, CAPA, change controls, risk assessments, effectiveness checks, shipping validations, SOPs and internal/external audits.
- Support Operations with the review and approval of artwork changes.
- Assist the Global Quality Team with additional quality activities as required.
- Promote a strong quality culture and participate in personal and cross-functional training.
- Support or lead ad hoc project development activities.
Qualifications & Experience
- BSc in a science-related discipline; a pharmaceutical specialism is advantageous.
- At least 2 years’ experience in the pharmaceutical industry within a GMP environment, including routine QA and quality systems activities.
Skills & Knowledge
Technical & Functional
- Strong knowledge of GMP and working knowledge of global pharmaceutical regulations, including FDA 21 CFR Parts 210/211, EU GMP Annexes and PIC/S guidelines.
- Understanding of data integrity principles (ALCOA++), QMS requirements and ICH Q10.
- Experience writing deviation, CAPA and change control reports; risk assessment skills and familiarity with ICH Q9.
- Competence using eQMS platforms and knowledge of EU GMP Annex 11 and 21 CFR Part 11.
- Strong Microsoft Office skills, including Word, Excel, Visio, PowerPoint, Project and SharePoint, for reporting, trending, process flows and presentations.
Analytical & Interpersonal
- Data trending, root cause analysis, problem-solving and issue resolution.
- Strong attention to detail, accuracy, critical thinking and decision-making.
- Effective communication across global teams, stakeholder engagement, adaptability and a proactive approach.